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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K242205
Device Name SpectoMed (v1.0)
Applicant
Specto Medical
Elisabethenstrasse 18
Basel,  CH 4051
Applicant Contact Charly Leprince
Correspondent
MCRA LLC
Elisabethenstrasse 18
4051 Basel, Switzerland
CH
Correspondent Contact Charly Leprince
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/26/2024
Decision Date 01/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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